Bioavailability and Bioequivalence of Ezetimibe Tablets in Healthy Subjects

Hyperlipidemias Clinical Trial

Official title:

Study on the Bioavailability and Bioequivalence of Ezetimibe Tablets in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05681247
• Other study ID #: SHX-BE-201703
• Status: Completed
• Phase: Phase 1
• Start date: December 17, 2017
• Est. completion date: March 7, 2018

Study information

• Verified date: December 2022
• Source: The Affiliated Hospital of Qingdao University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was conducted to assess the bioequivalence of the ezetimibe tablet to Ezetrol ® in healthy Chinese volunteers and estimate the pharmacokinetic profiles of ezetimibe tablet.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: March 7, 2018
• Est. primary completion date: January 29, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Healthy male or female subjects =18 years of age

• The body mass index is in the range of 18.0-26.0 kg/m2 (including the critical value).

• The weight of male is not less than 50.0 kg, and that of female is not less than 45.0 kg.

• Serum total cholesterol was between 2.9 and 5.0mmol/L (not including critical value).

Exclusion Criteria:

• any medical history of cardiovascular, digestive, respiratory, nervous or ematological diseases

• hepatic/renal impairment

• abnormal vital signs

• drug or alcohol abuse

• smoking =5 cigarettes per day ,

• donation(=300ml) o

• enrollment in other clinical trials during the 3 months prior to screening

• allergic to ezetimibe or its excipients

• any use of other prescription drugs or vitamins or caffeine/xanthine-rich beverages 48h prior to taking medication

• lactating or pregnant women

Related Conditions & MeSH terms

• Hyperlipidemias

Intervention

Drug:
• ezetimibe tablet
The subjects randomly received single oral administration of ezetimibe tablet 10 mg
• ezetimibe tablet(Ezetrol ®)
The subjects randomly received single oral administration of ezetimibe tablet (Ezetrol ®) 10 mg.

Locations

Country	Name	City	State
China	Clinical Research Center	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of Qingdao University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Plasma Concentration (Cmax) Peak Plasma Concentration (Cmax)	Peak Plasma Concentration (Cmax) Evaluation of Peak Plasma Concentration (Cmax)	80 days
Secondary	Area under the plasma concentration versus time curve (AUC)0-t	Evaluation of Area under the plasma concentration versus time curve (AUC)0-t	80 days